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Demodex Blepharitis Treatment Study (DBTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01647217
Recruitment Status : Completed
First Posted : July 23, 2012
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
National Eye Institute (NEI)
Information provided by (Responsible Party):
Tissue Tech Inc.

Brief Summary:
This is a randomized clinical trial to determine the safety and efficacy of terpinen-4-ol (T4O), the most active ingredient of tea tree oil (TTO), in eradicating ocular demodicosis (reducing ocular demodex counts and achieving the clinical improvement with minimal or no irritation).

Condition or disease Intervention/treatment Phase
Chronic Blepharitis Drug: Terpinen-4-ol Other: Placebo Phase 1

Detailed Description:
Demodex blepharitis is one of the most common causes of chronic blepharitis. The investigators preliminary clinical study showed that lid scrub with TTO was effective in resolving chronic blepharoconjunctivitis; however, it was not convenient for self-administration and caused irritation in some patients. Preclinical safety studies have verified that T4O is less irritant. In this study, the investigators will determine the optimal regimen of T4O Pads.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial
Study Start Date : February 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: Terpinen-4-ol Treatment Arm
8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Drug: Terpinen-4-ol
Lid scrub once or twice per day for one month.
Other Name: T4O

Placebo Comparator: Placepo Pads Contol Arm
9 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Other: Placebo
Lid scrub once or twice per day for one month

Primary Outcome Measures :
  1. Change in the Number of Demodex Mites [ Time Frame: 6 weeks ]
    Change in mites count after treatment compared to the baseline data. If the mites' count remains zero during the last two visits, it is considered "complete eradication". Patients without achieving complete eradication will be categorized as "incomplete eradication".

Secondary Outcome Measures :
  1. Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia [ Time Frame: Baseline and 6 weeks ]
    Lid margin redness and bulbar conjunctival hyperemia were each assessed using an ordered categorical value ranging from 0 (None) to 3 (Severe). The two scores were summed to obtain the final score, which ranges from 0 (None) to 6 (Severe).

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with symptomatic Demodex blepharitis for duration of at least 3 months.
  • Age range: 15-80 years old.
  • Both genders and all ethnic groups comparable with the local community.
  • Able to understand and willing to sign a written informed consent
  • Able and willing to cooperate with the investigational plan.
  • Able and willing to complete all mandatory follow-up visits.

Exclusion Criteria:

  • Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.
  • Children under 15.
  • Pregnant women or expecting to be pregnant during the study.
  • Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
  • Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).
  • Concomitant use of systemic antibiotics or steroids.
  • Contact lens wear (unless discontinued for ≥ 30 days before randomization)
  • Active ocular infection or allergy
  • Unable to close eyes or uncontrolled blinking
  • Presence of aqueous tear deficient dry eye defined by the Fluorescein Clearance Test as less than 3 mm wetting in 1-minute Schirmer test with anesthesia.
  • Previous allergic reaction to TTO-containing products or cosmetic fragrance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01647217

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United States, Florida
Ocular Surface Center
Miami, Florida, United States, 33173
Sponsors and Collaborators
Tissue Tech Inc.
National Eye Institute (NEI)
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Study Chair: Scheffer CG Tseng, MD, PhD Tissue Tech Inc.

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Responsible Party: Tissue Tech Inc. Identifier: NCT01647217    
Other Study ID Numbers: P012-01
2R44EY019586-02 ( U.S. NIH Grant/Contract )
First Posted: July 23, 2012    Key Record Dates
Results First Posted: July 26, 2017
Last Update Posted: July 26, 2017
Last Verified: May 2017
Keywords provided by Tissue Tech Inc.:
Tea Tree oil
Additional relevant MeSH terms:
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Eyelid Diseases
Eye Diseases